RFI PWS CART 2024 Renewal 5-6-24.docx

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DA01--Clinical Assessment, Reporting and Tracking - CART RFI VA-24-00011768
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This document is a Request for Information (RFI) from the Department of Veterans Affairs (VA) Technology Acquisition Center Austin for the Clinical Assessment, Reporting and Tracking (CART) program. The RFI includes a draft Performance Work Statement (PWS) and is seeking information from interested vendors to assist the VA in developing its acquisition strategy.

The VA is requesting information on vendors' capabilities to meet the requirements outlined in the draft PWS, which include maintenance and support of the existing CART Application Suite, as well as incorporating enhancements to add new functionality. Vendors are asked to provide a summary of their capabilities, an estimated Rough Order of Magnitude, and information on their ability to meet the Service-Disabled Veteran-Owned Small Business (SDVOSB) set-aside requirement. Responses are due by May 13, 2024, and should not exceed 5 pages. The VA does not intend to pay for the information submitted in response to this RFI.

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CART Program Services

VA-24-00011768

PERFORMANCE WORK STATEMENT (PWS)

DEPARTMENT OF VETERANS AFFAIRS

Office of Information & Technology Office of Clinical Assessment, Reporting and Tracking (CART) Program

Clinical Assessment, Report and Tracking (CART) Program

Date: 5/6/2024

VA-24-00011768

PWS Version Number: 2.0

Contents

1.0BACKGROUND3
2.0APPLICABLE DOCUMENTS3
3.0SCOPE OF WORK7
4.0PERFORMANCE DETAILS7
4.1PERFORMANCE PERIOD7
4.2PLACE OF PERFORMANCE8
4.3TRAVEL8
5.0SPECIFIC TASKS AND DELIVERABLES8
5.1PROJECT MANAGEMENT8
5.1.1CONTRACTOR PROJECT MANAGEMENT PLAN8
5.1.2REPORTING REQUIREMENTS8
5.2CART MAINTENANCE, MODIFICATIONS AND ENHANCEMENTS9
5.2.1MAINTENANCE AND SUPPORT9
5.2.2ENHANCEMENTS11
5.3CROSS-TRAINING OF CART PROGRAM PERSONNEL12
5.4OPTION PERIOD ONE12
5.5OPTION PERIOD TWO13
6.0GENERAL REQUIREMENTS13
6.1ENTERPRISE AND IT FRAMEWORK13
6.1.1VA TECHNICAL REFERENCE MODEL13
6.1.2FEDERAL IDENTITY, CREDENTIAL, AND ACCESS MANAGEMENT (FICAM)14
6.1.3INTERNET PROTOCOL VERSION 6 (IPV6)15
6.1.4TRUSTED INTERNET CONNECTION (TIC)16
6.1.5STANDARD COMPUTER CONFIGURATION16
6.1.6VETERAN FOCUSED INTEGRATION PROCESS (VIP) AND PRODUCT LINE MANAGEMENT (PLM)16
6.1.7PROCESS ASSET LIBRARY (PAL)17
6.1.8AUTHORITATIVE DATA SOURCES17
6.1.9SOCIAL SECURITY NUMBER (SSN) REDUCTION18
6.1.10SOFTWARE AND LICENSING REQUIREMENTS18
6.2SECURITY AND PRIVACY REQUIREMENTS19
6.2.1POSITION/TASK RISK DESIGNATION LEVEL(S)19
6.2.2CONTRACTOR PERSONNEL SECURITY REQUIREMENTS19
6.3METHOD AND DISTRIBUTION OF DELIVERABLES21
6.4PERFORMANCE METRICS21
6.5FACILITY/RESOURCE PROVISIONS22
6.6GOVERNMENT FURNISHED PROPERTY23
ADDENDUM A – ADDITIONAL VA REQUIREMENTS, CONSOLIDATED25
ADDENDUM B – VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE31
ADDENDUM C - CART INSTALLATION LOCATIONS43

BACKGROUND

The Department of Veterans Affairs (VA), Office of Information & Technology (OIT), Office of Clinical Assessment, Reporting and Tracking (CART) strives to provide high quality, effective, and efficient Information Technology (IT) services to those responsible for providing care to the Veterans at the point-of-care as well as throughout all the points of the Veterans’ health care in an effective, timely and compassionate manner. VA depends on Information Management/Information Technology (IM/IT) systems to meet mission goals.

Professional society guidelines have recommended that all cardiac catheterization laboratories should participate in procedural registries with structured data reporting to monitor the quality of interventional care as well as to provide benchmarks related to national norms (Journal of American College of Cardiology, 59(24): 2221, 2012 and Journal of American College of Cardiology, 63(23): 2591, 2014).

The Clinical Assessment, Reporting and Tracking (CART) Program was created to monitor the quality and safety of invasive cardiac procedures within the VA Healthcare System. To do so, the CART Program has led the development of a standalone software application (CART Application Suite [CART-APPS]) that is now fully integrated with the Computerized Patient Record System (CPRS) and Oracle Health. This enables providers to reuse and annotate existing Veterans Health Information Systems and Technology Architecture (VISTA) data including information regarding medical comorbidities and medications. The application also allows for the input of discrete information for pre-procedural assessments, diagnostic coronary procedures and percutaneous coronary interventions. After operators complete this information within the dedicated software application, a standardized procedural report is then automatically created which can be uploaded into the permanent electronic medical record. The application also stores procedural information in a standard relational database that can be easily deployed and migrated to any Structure Query Language (SQL) database system. The application can also be configured to connect via the VA internet to a single national database server that serves all cardiac catheterization laboratories or a series of locally deployed servers with automatic rollup to the national server, giving medical centers the flexibility to choose a deployment structure that best meets the available resources. The data retrieved within the application is then monitored by the CART Program to enhance the quality and safety of invasive cardiovascular procedures. CART was mandated to be a national program for use in all 81 catheterization laboratories in the VA system by the Deputy Undersecretary for Health and is a unique collaborative effort involving Patient Care Services, and the Office of Information, Office of Quality and Performance.

APPLICABLE DOCUMENTS

In the performance of the tasks associated with this Performance Work Statement, the Contractor shall comply with the following:

1. 44 U.S.C. § 3541-3549, “Federal Information Security Management Act (FISMA) of 2002”

2. “Federal Information Security Modernization Act of 2014”

3. Federal Information Processing Standards (FIPS) Publication 140-2, “Security Requirements for Cryptographic Modules”

4. FIPS Pub 199. “Standards for Security Categorization of Federal Information and Information Systems,” February 2004

5. FIPS Pub 200, “Minimum Security Requirements for Federal Information and Information Systems,” March 2006

6. FIPS Pub 201-2, “Personal Identity Verification of Federal Employees and Contractors,” August 2013

7. 10 U.S.C. § 2224, "Defense Information Assurance Program"

8. 5 U.S.C. § 552a, as amended, “The Privacy Act of 1974”

9. Public Law 109-461, Veterans Benefits, Health Care, and Information Technology Act of 2006, Title IX, Information Security Matters

10. 42 U.S.C. § 2000d “Title VI of the Civil Rights Act of 1964”

11. VA Directive 0710, “Personnel Security and Suitability Program,” June 4, 2010, https://www.va.gov/vapubs/index.cfm

12. VA Handbook 0710, “Personnel Security and Suitability Program,” May 2, 2016, https://www.va.gov/vapubs/index.cfm

13. VA Directive and Handbook 6102, “Internet/Intranet Services,” August 5, 2019

14. 36 C.F.R. Part 1194 “Information and Communication Technology Standards and Guidelines,” January 18, 2017

15. Office of Management and Budget (OMB) Circular A-130, “Managing Federal Information as a Strategic Resource,” July 28, 2016

16. 32 C.F.R. Part 199, “Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)”

17. NIST SP 800-66 Rev. 1, “An Introductory Resource Guide for Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule,” October 2008

18. Sections 504 and 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended, January 18, 2017

19. Homeland Security Presidential Directive (12) (HSPD-12), August 27, 2004

20. VA Directive 6500, “VA Cybersecurity Program,” February 24, 2021

21. VA Handbook 6500, “Risk Management Framework for VA Information Systems VA Information Security Program,” February 24, 2021

22. VA Handbook 6500.2, “Management of Breaches Involving Sensitive Personal Information (SPI),” March 12, 2019

23. VA Handbook 6500.5, “Incorporating Security and Privacy into the System Development Lifecycle,” March 22, 2010

24. VA Handbook 6500.6, “Contract Security,” March 12, 2010

25. VA Handbook 6500.8, “Information System Contingency Planning,” April 6, 2011

26. VA Handbook 6500.10, “Mobile Device Security Policy,” February 15, 2018

27. VA Handbook 6500.11, “VA Firewall Configuration,” August 22, 2017

28. OIT Process Asset Library (PAL), https://www.va.gov/process/ . Reference Process Maps at https://www.va.gov/process/maps.asp and Artifact templates at https://www.va.gov/process/artifacts.asp

29. One-VA Technical Reference Model (TRM) (reference at https://www.va.gov/trm/TRMHomePage.aspx)

30. VA Directive 6508, “Implementation of Privacy Threshold Analysis and Privacy Impact Assessment,” October 15, 2014

31. VA Handbook 6508.1, “Procedures for Privacy Threshold Analysis and Privacy Impact Assessment,” July 30, 2015

32. VA Handbook 6510, “VA Identity and Access Management,” January 15, 2016

33. VA Directive and Handbook 6513, “Secure External Connections,” October 12, 2017

34. VA Directive 6300, “Records and Information Management,” September 21, 2018

35. VA Handbook, 6300.1, “Records Management Procedures,“ March 24, 2010

36. NIST SP 800-37 Rev 2, “Risk Management Framework for Information Systems and Organizations: A System Life Cycle Approach for Security and Privacy,” December 2018

37. NIST SP 800-53 Rev. 5, “Security and Privacy Controls for Federal Information Systems and Organizations,” September 23, 2020 (includes updates as of 12/10/2020)

38. VA Directive 0735, “Homeland Security Presidential Directive 12 (HSPD-12) Program,” October 26, 2015

39. VA Handbook 0735, “Homeland Security Presidential Directive 12 (HSPD-12) Program,” March 24, 2014

40. OMB Memorandum 05-24, “Implementation of Homeland Security Presidential Directive (HSPD) 12 – Policy for a Common Identification Standard for Federal Employees and Contractors,” August 5, 2005

41. OMB Memorandum M-19-17, “Enabling Mission Delivery Through Improved Identity, Credential, and Access Management,” May 21, 2019

42. OMB Memorandum, “Guidance for Homeland Security Presidential Directive (HSPD) 12 Implementation,” May 23, 2008

43. Federal Identity, Credential, and Access Management (FICAM) Roadmap and Implementation Guidance, December 2, 2011, (NOTE: Part A of the FICAM Roadmap and Implementation Guidance, v2.0, was replaced in 2015 with an updated Architecture (https://arch.idmanagement.gov/#what-is-the-ficam-architecture)

44. NIST SP 800-116 Rev 1, “Guidelines for the Use of Personal Identity Verification (PIV) Credentials in Facility Access,“ June 2018

45. NIST SP 800-63-3, 800-63A, 800-63B, 800-63C, “Digital Identity Guidelines,” updated March 02, 2020

46. NIST SP 800-157, “Guidelines for Derived PIV Credentials,” December 2014

47. NIST SP 800-164, “Guidelines on Hardware-Rooted Security in Mobile Devices (Draft),” October 2012

48. Draft National Institute of Standards and Technology Interagency Report (NISTIR) 7981, “Mobile, PIV, and Authentication,” March 2014

49. VA Memorandum, VAIQ #7100147, “Continued Implementation of Homeland Security Presidential Directive 12 (HSPD-12),” April 29, 2011 (reference https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514)

50. IAM Identity Management Business Requirements Guidance document, May 2013, (reference Enterprise Architecture Section, PIV/IAM (reference https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514)

51. VA Memorandum “Personal Identity Verification (PIV) Logical Access Policy Clarification,” July 17, 2019, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4896

52. Trusted Internet Connections (TIC) 3.0 Core Guidance Documents, https://www.cisa.gov/publication/tic-30-core-guidance-documents

53. OMB Memorandum M-19-26, “Update to the Trusted Internet Connections (TIC) Initiative,” September 12, 2019

54. OMB Memorandum M-08-23, “Securing the Federal Government’s Domain Name System Infrastructure,” August 22, 2008

55. Sections 524 and 525 of the Energy Independence and Security Act of 2007, (Public Law 110–140), December 19, 2007

56. Section 104 of the Energy Policy Act of 2005, (Public Law 109–58), August 8, 2005

57. Executive Order 13834, “Efficient Federal Operations,” dated May 17, 2018

58. Executive Order 13221, “Energy-Efficient Standby Power Devices,” August 2, 2001

59. VA Directive 0058, “VA Green Purchasing Program,” July 19, 2013

60. VA Handbook 0058, “VA Green Purchasing Program,” July 19, 2013

61. Office of Information Security (OIS) VAIQ #7424808 Memorandum, “Remote Access,” January 15, 2014, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

62. Clinger-Cohen Act of 1996, 40 U.S.C. §11101 and §11103

63. “Veteran Focused Integration Process (VIP) Guide 4.0,” January 2021, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371

64. VA Memorandum “Proper Use of Email and Other Messaging Services,” January 2, 2018, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

65. “DevSecOps Product Line Management Playbook” version 2.0, May 2021, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4946

66. NIST SP 500-267B Revision 1, “USGv6 Profile,” November 2020

67. OMB Memorandum M-21-07, “Completing the Transition to Internet Protocol Version 6 (IPv6),” November 19, 2020

68. Social Security Number (SSN) Fraud Prevention Act of 2017

69. Section 240 of the Consolidated Appropriations Act (CAA) 2018, March 23, 2018

70. CATH/PCI Registry: https://www.ncdr.com/webncdr/cathpci

71. ACC NCDR ICD Registry: https://www.ncdr.com/webncdr/icd

72. ACC/NCRD PVI Registry: https://www.ncdr.com/webncdr/pvi

73. ACC/NCDR STS/ACC TVT Registry: https://www.ncdr.com/TVT/Home/Default.aspx

SCOPE OF WORK

The Contractor shall be responsible for the maintenance and support of the existing CART Application Suite, as well as incorporating enhancements to add new functionality to support clinical care of Veterans.

PERFORMANCE DETAILS

0. PERFORMANCE PERIOD

The Period of Performance (PoP) shall be one 12-month base period, with two (2) 12-month Option Periods.

Any work at the Government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO).

There are eleven (11) Federal holidays set by law (USC Title 5 Section 6103) that VA follows:

Under current definitions, four are set by date:

New Year's DayJanuary 1
JuneteenthJune 19
Independence DayJuly 4
Veterans DayNovember 11
Christmas DayDecember 25

If any of the above falls on a Saturday, then Friday shall be observed as a holiday. Similarly, if one falls on a Sunday, then Monday shall be observed as a holiday.

The other six are set by a day of the week and month:

Martin Luther King's BirthdayThird Monday in January
Washington's BirthdayThird Monday in February
Memorial DayLast Monday in May
Labor DayFirst Monday in September
Columbus DaySecond Monday in October
ThanksgivingFourth Thursday in November

PLACE OF PERFORMANCE

Tasks under this PWS shall be performed at remote locations with prior approval of the Contracting Officer’s Representative (COR).

TRAVEL

The Government does not anticipate travel under this effort to perform the tasks associated with the effort. Include any estimated travel costs in your firm-fixed price line items. These costs will not be directly reimbursed by the Government.

SPECIFIC TASKS AND DELIVERABLES

The Contractor shall perform the following:

PROJECT MANAGEMENT

The Contractor shall participate with the CART Program personnel during regular conference calls and face-to-face meetings with the CART Program personnel at least three times per week, as well as biweekly one-on-one meetings with the Program Director regarding progress on deliverables.

CONTRACTOR PROJECT MANAGEMENT PLAN

The Contractor shall deliver a Contractor Project Management Plan (CPMP) that lays out the Contractor’s approach, timeline, and tools to be used in execution of the contract. The CPMP should take the form of both a narrative and graphic format that displays the schedule, milestones, risks, and resource support. The CPMP shall also include how the Contractor shall coordinate and execute planned, routine, and ad hoc data collection reporting requests as identified within the PWS. The initial baseline CPMP shall be concurred upon and updated in accordance with Section B of the contract. The Contractor shall update and maintain the VA PM approved CPMP throughout the PoP.

Deliverable:

A. Contractor Project Management Plan

REPORTING REQUIREMENTS

The Contractor shall provide the Contracting Officer’s Representative (COR) with a Quarterly Progress and Maintenance Report. The Quarterly Progress and Maintenance Reports shall cover all work completed during the reporting period, work planned for the subsequent reporting period, and note any updates or changes to the initial CPMP. Sections of this report shall include: Clinical/Technical Tradeoff Analysis Report; Clinical/Technical Prioritization Report; Implementation Plan, Regression Testing Plan, Autotest Updates and Autotest Tracking Report, and a Deployment Scheduling and Tracking Report. The report shall also identify any problems that arose and a description of how the problems were resolved. If problems have not been completely resolved, the Contractor shall provide an explanation including their plan and timeframe for resolving the issue. The Contractor shall monitor performance against the CPMP and report any deviations. The Contractor will keep in communication with VA accordingly, so that issues that arise are transparent to both parties to prevent escalation of outstanding issues. The Contractor shall also include the status of all Government Furnished Equipment (GFE) in each Quarterly Progress and Maintenance Report.

The Contractor shall coordinate changes involved with these modifications and enhancements with the VA CART Clinical Program Director, the VA CART Database Manager and the CART National Site manager as appropriate.

The Contractor shall participate in the weekly CART Program meetings for ongoing project management review with VA Program Director and staff.

Deliverable:

A. Quarterly Progress and Maintenance Report

CART MAINTENANCE, MODIFICATIONS AND ENHANCEMENTS

MAINTENANCE AND SUPPORT

The Contractor shall provide maintenance for the existing Clinical Assessment Reporting and Tracking Application Suite (CART-APPS), and ensure CART-APPS is operational 99% of the time at all installed sites listed in ADDENDUM C – CART INSTALLATION LOCATIONS. CART-APPS is built on top of an object-relational model-driven infrastructure using dynamic late binding of application specifications to run-time objects. Maintenance shall include updating the CART-APPS interfaces, using the Delphi and SQL Data programming languages, including: VA VistA Remote Procedure Call (RPC) Broker for access to VistA databases, VA Decision Support System (DSS) for workload and costing and the new VA Real-Time Locator Services (RTLS) for supply chain management of products such as devices and supply items used in the VA Cath labs. CART-APPS is currently being used by over 2,000 users nationally across 81 locations to facilitate the work of the CART Program. The Contractor shall be available 24X7 to provide support for the CART-APPS and respond via e-mail or phone within four (4) hours of being contacted by the CART Program. Support shall include defect fixes for the applications and related databases including:

1. Trouble shooting

2. Coding or configuration to resolve or fix errors and defects

3. Testing/verification of fixes

4. Adaptation and testing with new MS Windows versions (such as Windows 10)

5. Deployment of new versions

The Contractor shall ensure maintenance for the CART-APPs software under this task does not change the salient characteristics of the CART-APPs. The salient characteristics of the CART-APPs software are:

1. The software leverages a powerful object-relational model-driven dynamic late-binding run-time architecture to manage all the internal data, data relationships, report generation, and user inputs.

1. The software uses a configuration specification to provide information about how the application should function to the architecture, allowing changes to be made through simple specification changes instead of changing the source code associated with the software.

1. The software collects data relevant to the CART Program and the National Cardiology Program Office as identified by industry standards, current research, and VA Clinician feedback on all Cardiology procedures performed in the VA and produces a nationally standardized set of reports for inclusion in patient medical history.

1. The software is tightly integrated with the VISTA/CPRS system as well as Oracle Health and uses it for patient selection, security, data import and data upload.

1. The software complies with all the rules, regulations, and security protocols mandated by VA, Federal Law, and health care oversight organizations, such as The Joint Commission (JACO) authorized by the VA, and must adjust to any new requirements by any of these organizations within a reasonable timeframe.

1. The software interfaces with the VA’s Real Time Locator System (RTLS) and imports information about devices tracked by RTLS that are used during procedures to provide more accurate accounting of devices and reduce the amount of data entry required by users of the application.

1. The software is implemented to permit multiple release versions of the software to operate against the same database. This permits the software upgrade process to happen as each individual hospital approves the update instead of requiring all sites to update simultaneously.

1. The software facilitates procedure coding by mapping all procedures performed into Clinical Procedure Type (CPT) codes.

1. The software produces a list of problems encountered with devices used so that this information can be submitted to the Food and Drug Administration’s (FDA) Device Surveillance program.

1. The software automatically provides alerts when major complications are encountered during procedures and forwards these alerts to a clinical patient safety review team for investigation.

1. The software incorporates feedback from the VA, VA Clinicians, and other end users into the design and implementation of new features.

1. The software provides security roles that limit the scope of the data that users can view and modify, and these security roles also limit access to management features that allow each individual software installation to manage their own location’s settings and users.

1. The software uses a sharing and protection mechanism to reuse data elements from previous reports whenever possible to avoid creating duplicated data and to prevent adjustments to shared data.

1. The software logs key user actions and any error messages produced by the application into a database table to facilitate support and maintenance of the application.

1. The software includes specialized graphical controls and control contents that are dynamically generated based on the contents of key reference tables in the database, so that changes in reference tables will automatically generate graphical control changes and changes in graphical control content without requiring source code or programming changes.

1. The software provides the ability to calculate and display health status scores and analytic measurements based on data collected by the software.

1. The software produces a data dictionary based on the internal application model and current application specification that provides a baseline for published data dictionary updates for software users.

1. Maintenance of the CART application includes:

17. Telephone and email support that is available during normal business hours.

17. Examination of application and database log files

17. Routine Backups of the CART database based on VA Policies and Procedures

17. Routine patching of CART servers based on VA Policies and Procedures

17. Activating and deactivating users

17. Adjusting user roles and permissions

17. Installing upgrades to the application at each hospital

ENHANCEMENTS

The Contractor shall develop and install enhancements to existing CART-APPS per feedback from the CART Clinical Director and CART Clinical Advisory subcommittee. This shall include assistance with prioritization, developing time and resource estimates, implementation and testing of modifications to the CART-APPS and the database and the deployment to all installed sites.

Enhancements to the CART-APPS and database are defined as being within the existing CART system, CART applications and database platform and require no changes to the underlying architecture and infrastructure.

The Contractor shall provide the following enhancements to the CART system:

1. Integration of alternative data fields into CART-APPS, as dictated by CART Program leadership (up to 20 fields)

1. Integration of a revised coronary intervention module

1. Enhancement of an electrophysiology module

1. Enhancement of a cardiac implantable electronic device module

The Contractor shall provide Updated Requirement Specification Document (RSD), Updated System Design Document (SDD), and Updated Test Plans/Procedures (TP/P), and the Modified/Enhanced CART System/Applications Software.

CROSS-TRAINING OF CART PROGRAM PERSONNEL

The Contractor shall provide technical cross-training to CART Program personnel, approximately two (2) to five (5) people, to build a robust team to provide ongoing maintenance, support and development of the CART Application Suite. This training shall take place in small, informal, on-the-job sessions. Initial training shall enable CART Program team members to perform development and support tasks (listed below) with minimal guidance by the end of the base period and progress through the life of the contract whereby the CART Program team will be able to perform these tasks without guidance by the end of this contract. These development and support tasks include:

1. Add new applications and perform application enhancements.

2. Adaptation to new MS Windows versions.

3. CERNER-CART-APPS integration development and support.

4. Support deployment of new CART versions.

5. Handle all other CART support issues.

The Contractor shall provide a detailed CART Training Manual that shall cover the overall CART system, maintenance and system update requirements.

Deliverable:

A. CART Training Materials

OPTION PERIOD ONE

The Contractor shall provide all the tasks and services identified in Sections 5.1 and 5.2.1 throughout Option Period One. The Contractor shall also perform all of the tasks and services for sections 5.2.2 for the enhancements specified below and for 5.3 for the training requirements listed below:

From section 5.2.2 Enhancements:

1. Integration of alternative data fields into CART-APPS, as dictated by CART Program leadership (up to 20 fields) to enhance the coronary interventional module.

2. RTLS Level-2 data integration with CART-CL, CART-EP and CART-PVI (Note: Applies only to CART sites with Wavemark RTLS setup).

From section 5.3 Cross training of CART Program Personnel:

1. Add new applications and perform application enhancement without guidance.

2. Adaptation to new MS Windows version without guidance.

3. CPRS RPC broker support without guidance.

4. Support deployment of new CART versions without guidance.

5. Handle all other CART support issues without guidance.

6. Perform difficult trouble shooting task with minor guidance.

OPTION PERIOD TWO

The Contractor shall provide all the tasks and services identified in Sections 5.1 and 5.2.1 throughout Option Period Two. The Contractor shall also perform all of the tasks and services for sections 5.2.2 for the enhancements specified below and for 5.3 for the training requirements listed below.

From section 5.2.2 Enhancements:

1. Integration of alternative data fields into CART-APPS, as dictated by CART Program leadership (up to 20 fields) to enhance the electrophysiology and cardiac implantable electronic device modules

2. RTLS Level-3 data integration with CART-CL, CART-EP and CART-PVI (Note: Applies only to CART sites with Wavemark RTLS setup).

From section 5.3 Cross training of CART Program Personnel:

1. Perform all development and support tasks without guidance.

2. Add new applications and perform application enhancement without guidance.

3. Adaptation to new MS Windows version without guidance

4. CPRS RPC broker support without guidance

5. Support deployment of new CART versions without guidance

6. Handle all other CART support issues without guidance.

7. Perform difficult trouble shooting task with minor guidance.

GENERAL REQUIREMENTS

ENTERPRISE AND IT FRAMEWORK

VA TECHNICAL REFERENCE MODEL

The Contractor shall support the VA enterprise management framework. In association with the framework, the Contractor shall comply with OIT Technical Reference Model (VA TRM). The VA TRM is one component within the overall Enterprise Architecture (EA) that establishes a common vocabulary and structure for describing the information technology used to develop, operate, and maintain enterprise applications. Moreover, the VA TRM, which includes the Standards Profile and Product List, serves as a technology roadmap and tool for supporting OIT. Architecture & Engineering Services (AES) has overall responsibility for the VA TRM.

FEDERAL IDENTITY, CREDENTIAL, AND ACCESS MANAGEMENT (FICAM)

The Contractor shall ensure Commercial Off-The-Shelf (COTS) product(s), software configuration and customization, and/or new software are Personal Identity Verification (PIV) card-enabled by accepting HSPD-12 PIV credentials using VA Enterprise Technical Architecture (ETA), https://www.ea.oit.va.gov/EAOIT/VA_EA/Enterprise_Technical_Architecture.asp, and VA Identity and Access Management (IAM) approved enterprise design and integration patterns, https://www.oit.va.gov/library/recurring/edp/index.cfm. The Contractor shall ensure all Contractor delivered applications and systems comply with the VA Identity, Credential, and Access Management policies and guidelines set forth in VA Handbook 6510 VA Identity and Access Management, VA Handbook 0735 Homeland Security Presidential Directive 12 (HSPD-12) Program, and align with the Federal Identity, Credential, and Access Management Roadmap and Implementation Guidance v2.0.

The Contractor shall ensure all Contractor delivered applications and systems provide user authentication services compliant with the National Institute of Standards and Technology (NIST) Special Publication (SP) 800-63-3, VA Handbook 6500 Appendix F, “VA System Security Controls”, and VA IAM enterprise requirements for direct, assertion based authentication, and/or trust based authentication, as determined by the design and integration patterns. Direct authentication at a minimum must include Public Key Infrastructure (PKI) based authentication supportive of PIV card and/or Common Access Card (CAC), as determined by the business need.

The Contractor shall ensure all Contractor delivered applications and systems conform to the specific Identity and Access Management PIV requirements set forth in the Office of Management and Budget (OMB) Memoranda M-05-24, M-19-17, and NIST Federal Information Processing Standard (FIPS) 201-2. OMB Memoranda M-05-24 and M-19-17 can be found at: https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2005/m05-24.pdf, and https://www.whitehouse.gov/wp-content/uploads/2019/05/M-19-17.pdf respectively. Contractor delivered applications and systems shall be on the FIPS 201-2 Approved Product List (APL). If the Contractor delivered application and system is not on the APL, the Contractor shall be responsible for taking the application and system through the FIPS 201 Evaluation Program.

The Contractor shall ensure all Contractor delivered applications and systems support:

1. Automated provisioning and are able to use enterprise provisioning service.

2. Interfacing with VA’s Master Person Index (MPI) to provision identity attributes, if the solution relies on VA user identities. MPI is the authoritative source for VA user identity data.

3. The VA defined unique identity (Secure Identifier [SEC ID] / Integrated Control Number [ICN]).

4. Multiple authenticators for a given identity and authenticators at every Authenticator Assurance Level (AAL) appropriate for the solution.

5. Identity proofing for each Identity Assurance Level (IAL) appropriate for the solution.

6. Federation for each Federation Assurance Level (FAL) appropriate for the solution, if applicable.

7. Two-factor authentication (2FA) through an applicable design pattern as outlined in VA Enterprise Design Patterns.

8. A Security Assertion Markup Language (SAML) implementation if the solution relies on assertion-based authentication. Additional assertion implementations, besides the required SAML assertion, may be provided as long as they are compliant with NIST SP 800-63-3 guidelines.

9. Authentication/account binding based on trusted Hypertext Transfer Protocol (HTTP) headers if the solution relies on Trust based authentication.

10. Role Based Access Control.

11. Auditing and reporting capabilities.

12. Compliance with VIEWS 00155984, PIV Logical Access Policy Clarification https://www.voa.va.gov/DocumentView.aspx?DocumentID=4896.

The required Assurance Levels for this specific effort are Identity Assurance Level 3, Authenticator Assurance Level 3, and Federation Assurance Level 3.

INTERNET PROTOCOL VERSION 6 (IPV6)

The Contractor solution shall support Internet Protocol Version 6 (IPv6) based upon the memo issued by the Office of Management and Budget (OMB) on November 19, 2020 (https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf). IPv6 technology, in accordance with the USGv6 Program (https://www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1), NIST Special Publication (SP) 500-267B Revision 1 “USGv6 Profile” (https://doi.org/10.6028/NIST.SP.500-267Br1), and NIST SP 800-119 “Guidelines for the Secure Deployment of IPv6” (https://doi.org/10.6028/NIST.SP.800-119), compliance shall be included in all IT infrastructures, application designs, application development, operational systems and sub-systems, and their integration. In addition to the above requirements, all devices shall support native IPv6 and dual stack (IPv6 / IPv4) connectivity without additional memory or other resources being provided by the Government, so that they can function in a mixed environment. All public/external facing servers and services (e.g. web, email, DNS, ISP services, etc.) shall support native IPv6 and dual stack (IPv6 / IPv4) users and all internal infrastructure and applications shall communicate using native IPv6 and dual stack (IPv6 / IPv4) operations.

TRUSTED INTERNET CONNECTION (TIC)

The Contractor solution shall meet the requirements outlined in Office of Management and Budget Memorandum M-19-26, “Update to the Trusted Internet Connections (TIC) Initiative“ (https://www.whitehouse.gov/wp-content/uploads/2019/09/M-19-26.pdf), VA Directive 6513 “Secure External Connections”, and shall comply with the TIC 3.0 Core Guidance Documents, including all Volumes and TIC Use Cases, found at the Cybersecurity & Infrastructure Security Agency (CISA) (https://www.cisa.gov/publication/tic-30-core-guidance-documents). Any deviations must be approved by the VA TIC 3.0 Working Group at vaoisesatic30team@va.gov.

STANDARD COMPUTER CONFIGURATION

The Contractor IT end user solution that is developed for use on standard VA computers shall be compatible with and be supported on the standard VA operating system, currently Windows 10 (64bit), Edge (Chromium based), and 365 Apps for enterprise. Applications delivered to VA and intended to be deployed to Windows 10 workstations shall be delivered as a signed .msi package with switches for silent and unattended installation and updates shall be delivered in signed .msp file formats for easy deployment using Microsoft Endpoint Configuration Manager (CM) VA’s current desktop application deployment tool. Signing of the software code shall be through a vendor provided certificate that is trusted by VA using a code signing authority such as Verizon/Cybertrust or Symantec/VeriSign. The Contractor shall also ensure and certify that their solution functions as expected when used from a standard VA computer, with non-admin, standard user rights that have been configured using the United States Government Configuration Baseline (USGCB) and Defense Information Systems Agency (DISA) Secure Technical Implementation Guide (STIG) specific to the particular client operating system being used.

VETERAN FOCUSED INTEGRATION PROCESS (VIP) AND PRODUCT LINE MANAGEMENT (PLM)

The Contractor shall support VA efforts IAW the updated Veteran Focused Integration Process (VIP) and Product Line Management (PLM). The major focus of the new VIP is on Governance and Reporting and is less prescriptive, with a focus on outcomes and continuous delivery of value. Product Line Management (PLM) is a framework that focuses on delivering functional products that provide the highest priority work to customers while delivering simplified, reliable, and practical solutions to the business, medical staff, and our Veterans. The VIP Guide is a companion guide to the PLM Playbook and can be found at: https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371 and the PLM Playbook can be found at https://www.voa.va.gov/DocumentView.aspx?DocumentID=4946. The PLM Playbook pivots from project-centric to product-centric delivery and contains descriptive practices that focuses on outcomes. The PLM Playbook contains a set of “plays” that implement Development, Security, and Operations (DevSecOps) principles and processes such as automated development, continuous integration/continuous delivery, and release on demand. The PLM Playbook details how product lines implement Lean-Agile principles, methods, practices, and techniques through levels of maturity. VIP and PLM are the authoritative processes that IT projects must follow to ensure development and delivery of IT products.

PROCESS ASSET LIBRARY (PAL)

The Contractor shall perform their duties consistent with the processes defined in the OIT Process Asset Library (PAL). The PAL scope includes the full spectrum of OIT functions and activities, such as VIP project management, operations, service delivery, communications, acquisition, and resource management. PAL serves as an authoritative and informative repository of searchable processes, activities or tasks, roles, artifacts, tools and applicable standards and guides to assist the OIT workforce, Government and Contractor personnel. The Contractor shall follow the PAL processes to ensure compliance with policies and regulations and to meet VA quality standards. The PAL includes the contractor onboarding process consistent with Section 6.2.2 and can be found at https://www.va.gov/PROCESS/artifacts/maps/process_CONB_ext.pdf. The main PAL can be accessed at www.va.gov/process.

AUTHORITATIVE DATA SOURCES

The VA Enterprise Architecture Repository (VEAR) is one component within the overall EA that establishes the common framework for data taxonomy for describing the data architecture used to develop, operate, and maintain enterprise applications. The Contractor shall comply with the department’s Authoritative Data Source (ADS) requirement that VA systems, services, and processes throughout the enterprise shall access VA data solely through official VA ADSs where applicable, see below. The Information Classes which compose each ADS are located in the VEAR, in the Data & Information domain. The Contractor shall ensure that all delivered applications and system solutions support:

1. Interfacing with VA’s Master Person Index (MPI) (formerly the Master Veteran Index (MVI)) to provision identity attributes, if the solution relies on VA user identities. MPI is the authoritative source for VA user identity data.

2. Interfacing with Capital Asset Inventory (CAI) to conduct real property record management actions, if the solution relies on real property records data. CAI is the authoritative source for VA real property record management data.

3. Interfacing with electronic Contract Management System (eCMS) for access to contract, contract line item, purchase requisition, offering vendor and vendor, and solicitation information above the micro-purchase threshold, if the solution relies on procurement data. ECMS is the authoritative source for VA procurement actions data.

4. Interfacing with HRSmart Human Resources Information System to conduct personnel action processing, on-boarding, benefits management, and compensation management, if the solution relies on personnel data. HRSmart is the authoritative source for VA personnel information data.

5. Interfacing with Vet360 to access personal contact information, if the solution relies on VA Veteran personal contact information data. Vet360 is the authoritative source for VA Veteran Personal Contact Data.

6. Interfacing with VA/Department of Defense (DoD) Identity Repository (VADIR) for determining eligibility for VA benefits under Title 38, if the solution relies on qualifying active duty military service data. VADIR is the authoritative source for Qualifying Active Duty military service in VA.

SOCIAL SECURITY NUMBER (SSN) REDUCTION

The Contractor solution shall support the Social Security Number (SSN) Fraud Prevention Act (FPA) of 2017 which prohibits the inclusion of SSNs on any document sent by mail. The Contractor support shall also be performed in accordance with Section 240 of the Consolidated Appropriations Act (CAA) 2018, enacted March 23, 2018, which mandates VA to discontinue using SSNs to identify individuals in all VA information systems as the Primary Identifier. The Contractor shall ensure that any new IT solution discontinues the use of SSN as the Primary Identifier to replace the SSN with the ICN in all VA information systems for all individuals. The Contractor shall ensure that all Contractor delivered applications and systems integrate with the VA Master Person Index (MPI) for identity traits to include the use of the ICN as the Primary Identifier. The Contractor solution may only use a Social Security Number to identify an individual in an information system if and only if the use of such number is required to obtain information VA requires from an information system that is not under the jurisdiction of VA.

SOFTWARE AND LICENSING REQUIREMENTS

The Contractor shall be responsible for the provision of all software licenses and any associated licensing maintenance required for any development, delivery, integration, operation, and/or maintenance associated with its proposed application(s), software products, software solution, and/or system including, but not limited to, any and all application(s), software and/or software products that comprise, are a part of, or integrate with the Contractor’s proposed application(s), software products, software solution, and/or system for the life of any resulting contract.

SECURITY AND PRIVACY REQUIREMENTS

It has been determined that protected health information may be disclosed or accessed and a signed Business Associate Agreement (BAA) shall be required. The Contractor shall adhere to the requirements set forth within the BAA, referenced in Section D of the contract, and shall comply with VA Directive 6066.

The Assessment and Authorization (A&A) requirements do not apply and a Security Accreditation Package is not required.

POSITION/TASK RISK DESIGNATION LEVEL(S)

In accordance with VA Handbook 0710, Personnel Security and Suitability Program, the position sensitivity and the level of background investigation commensurate with the required level of access for the following tasks within the PWS are:

Position Sensitivity and Background Investigation Requirements by Task

Task Number
Tier1 / Low Risk
Tier 2 / Moderate Risk
Tier 4 / High Risk
5.1
|X|
|_|
|_|
5.2
|_|
|X|
|_|
5.3
|X|
|_|
|_|
5.4
|_|
|X|
|_|
5.5
|_|
|X|
|_|
5.6
|_|
|X|
|_|

The Tasks identified above and the resulting Position Sensitivity and Background Investigation requirements identify, in effect, the Background Investigation requirements for Contractor individuals, based upon the tasks the particular Contractor individual will be working. The submitted Contractor Staff Roster must indicate the required Background Investigation Level for each Contractor individual based upon the tasks the Contractor individual will be working, in accordance with their submitted proposal.

CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

Contractor Responsibilities:

1. The Contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain the appropriate Background Investigation, and are able to read, write, speak, and understand the English language.

Within 3 business days after award, the Contractor shall provide a roster of Contractor and Subcontractor employees to the COR to begin their background investigations in accordance with the PAL template artifact. The Contractor Staff Roster shall contain the Contractor’s Full Name, Date of Birth, Place of Birth, individual background investigation level requirement (based upon Section 6.2 Tasks), etc. The Contractor shall submit full Social Security Numbers either within the Contractor Staff Roster or under separate cover to the COR. The Contractor Staff Roster shall be updated and provided to VA within 1 day of any changes in employee status, training certification completion status, Background Investigation level status, additions/removal of employees, etc. throughout the Period of Performance. The Contractor Staff Roster shall remain a historical document indicating all past information and the Contractor shall indicate in the Comment field, employees no longer supporting this contract. The preferred method to send the Contractor Staff Roster or Social Security Number is by encrypted e-mail. If unable to send encrypted e-mail, other methods which comply with FIPS 140-2 are to encrypt the file, use a secure fax, or use a traceable mail service.

1. The Contractor should coordinate with the location of the nearest VA fingerprinting office through the COR. Only electronic fingerprints are authorized. The Contractor shall bring their completed Security and Investigations Center (SIC) Fingerprint request form with them (see paragraph d.4. below) when getting fingerprints taken.

b. The Contractor shall ensure the following required forms are submitted to the COR within 5 days after contract award:

1) Optional Form 306

2) Self-Certification of Continuous Service

3) VA Form 0710

4) Completed SIC Fingerprint Request Form The Contractor personnel shall submit all required information related to their background investigations (completion of the investigation documents (SF85, SF85P, or SF 86) utilizing the Office of Personnel Management’s (OPM) Electronic Questionnaire for Investigations Processing (e-QIP) after receiving an email notification from the Security and Investigation Center (SIC).

The Contractor employee shall certify and release the e-QIP document, print, and sign the signature pages, and send them encrypted to the COR for electronic submission to the SIC. These documents shall be submitted to the COR within 3 business days of receipt of the e-QIP notification email. (Note: OPM is moving towards a “click to sign” process. If click to sign is used, the Contractor employee should notify the COR within 3 business days that documents were signed via e-QIP).

1. The Contractor shall be responsible for the actions of all personnel provided to work for VA under this contract. In the event that damages arise from work performed by Contractor provided personnel, under the auspices of this contract, the Contractor shall be responsible for all resources necessary to remedy the incident.

1. A Contractor may be granted unescorted access to VA facilities and/or access to VA Information Technology resources (network and/or protected data) with a favorably adjudicated Special Agreement Check (SAC), completed training delineated in VA Handbook 6500.6 (Appendix C, Section 9), signed “Contractor Rules of Behavior”, and with a valid, operational PIV credential for PIV-only logical access to VA’s network. A PIV card credential can be issued once your SAC has been favorably adjudicated and your background investigation has been scheduled by OPM. However, the Contractor will be responsible for the actions of the Contractor personnel they provide to perform work for VA. The investigative history for Contractor personnel working under this contract must be maintained in the database of OPM.

1. The Contractor, when notified of an unfavorably adjudicated background investigation on a Contractor employee as determined by the Government, shall withdraw the employee from consideration in working under the contract.

Failure to comply with the Contractor personnel security investigative requirements may result in loss of physical and/or logical access to VA facilities and systems by Contractor and Subcontractor employees and/or termination of the contract for default.

Identity Credential Holders must follow all HSPD-12 policies and procedures as well as use and protect their assigned identity credentials in accordance with VA policies and procedures, displaying their badges at all times, and returning the identity credentials upon termination of their relationship with VA.

Deliverable:

A. Contractor Staff Roster

METHOD AND DISTRIBUTION OF DELIVERABLES

The Contractor shall deliver documentation in electronic format, unless otherwise directed in Section B of the solicitation/contract. Acceptable electronic media include: Microsoft 365, MS Word 2000/2003/2007/2010/2019, MS Excel 2000/2003/2007/2010/2019, MS PowerPoint 2000/2003/2007/2010/2019, MS Project 2000/2003/2007/2010/2019, MS Access 2000/2003/2007/2010, MS Visio 2000/2002/2003/2007/2010/2019, AutoCAD 2002/2004/2007/2010, and Adobe Postscript Data Format (PDF).

PERFORMANCE METRICS

The table below defines the Performance Standards and Acceptable Levels of Performance associated with this effort.

Performance Objective
Performance Standard
Acceptable Levels of Performance
A. Technical / Quality of Product or Service
1. Demonstrates understanding of requirements

2. Efficient and effective in meeting requirements

3. Meets technical needs and mission requirements

4. Provides quality services/products Satisfactory or higher

B. Project Milestones and Schedule
1. Established milestones and project dates are met

2. Products completed, reviewed, delivered in accordance with the established schedule

3. Notifies customer in advance of potential problems Satisfactory or higher

C. Cost & Staffing
1. Currency of expertise and staffing levels appropriate to perform tasks required

2. Personnel possess necessary knowledge, skills and abilities to perform tasks Satisfactory or higher

D. Management
1. Integration and coordination of all activities to execute effort
Satisfactory or higher

The COR will utilize a Quality…

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